EUROPEAN RESPIRATORY JOURNAL RESEARCH LETTER S. DHOORIA ET AL. To the Editor:
|
|
- Valentine Hawkins
- 1 years ago
- Views:
Transcription
1 RESEARCH LETTER S. DHOORIA ET AL. High-dose versus low-dose prednisolone in symptomatic patients with post-covid-19 diffuse parenchymal lung abnormalities: an open-label, randomised trial (the COLDSTER trial) To the Editor: Copyright The authors This version is distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. For commercial reproduction rights and permissions contact Received: 21 Sept 2021 Accepted: 22 Nov 2021 In some patients, respiratory symptoms and imaging abnormalities persist after acute coronavirus disease 2019 (COVID-19) pneumonia [1 3]. Chest computed tomography (CT) scans generally show diffuse parenchymal lung abnormalities consistent with organising pneumonia [4]. It has been proposed that the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) could act as a trigger to exalt the presence of pre-existing interstitial lung abnormalities encountered in the general population, especially in smokers. Previous observational studies reported improvement with glucocorticoids in symptomatic patients with post-covid-19 diffuse parenchymal lung abnormalities (PC-DPLAS) [4 6]. A recent guideline recommended glucocorticoids for treating PC-DPLAS [3]. However, there are no randomised controlled trials on therapies for this condition. We conducted an investigator-initiated, single-centre, open-label, parallel-group, randomised, superiority trial of two doses of prednisolone at our institute. After institute ethics committee approval and protocol registration (COLDSTER trial; clinicaltrials.gov identifier number NCT ), we included consecutive, consenting subjects aged 18 years at 3 8 weeks from acute COVID-19 symptom onset, if they had 1) COVID-19 diagnosed by real-time reverse transcriptase PCR or COVID-19 antigen; 2) persistent dyspnoea (modified Medical Research Council (mmrc) score 2) or resting hypoxaemia (oxygen saturation 94%) or exertional desaturation ( 4% fall in oxygen saturation on exercise) at screening; and 3) diffuse abnormalities involving 20% of the lung parenchyma on semiquantitative assessment on thin-section (1.0 mm) CT. We excluded subjects with any of the following: 1) ongoing intensive care; 2) pre-existing structural lung disease; 3) pregnancy or lactation; and 4) contraindication for prednisolone. We allocated subjects 1:1 by computer-generated simple randomisation (allocation concealment in consecutively numbered sealed opaque envelopes) to receive either high-dose prednisolone (40 mg day 1 for 1 week, followed by 30 mg day 1 for 1 week, 20 mg day 1 for2weeksand10mg day 1 for 2 weeks) or low-dose prednisolone (10 mg day 1 for 6 weeks). We assessed the resting oxygen saturation, dyspnoea severity (mmrc scale) and 6-min walk test (6MWT) at randomisation. We monitored for treatment compliance and adverse effects by telephone at 2 and 4 weeks. At 6 weeks, we performed the following assessments: resting oxygen saturation, dyspnoea severity (mmrc scale and Functional Assessment of Chronic Illness Therapy 10-item dyspnoea questionnaire), 6MWT, spirometry, thin-section chest CT, respiratory health status (King s Brief Interstitial Lung Disease Questionnaire), health-related quality of life (HRQoL) using the short-form 36-item questionnaire, treatment compliance and treatment-related adverse effects [7 11]. We assessed the radiological response both by scoring for resolution of overall diffuse lung abnormalities and a systematic semiquantitative scoring for individual radiological abnormalities (table 1) [12, 13]. We evaluated all outcomes 6 weeks after randomisation. The primary outcome was the proportion of subjects with a complete radiological response ( 90% reduction in diffuse lung abnormalities) on CT. Shareable abstract (@ERSpublications) High-dose prednisolone may not be superior to a low-dose 6-week regimen in improving clinical, physiological and radiological outcomes, or health-related quality of life, in patients with symptomatic post-covid-19 diffuse parenchymal lung abnormalities Cite this article as: Dhooria S, Chaudhary S, Sehgal IS, et al. High-dose versus low-dose prednisolone in symptomatic patients with post-covid-19 diffuse parenchymal lung abnormalities: an open-label, randomised trial (the COLDSTER trial). Eur Respir J 2022; 59: [DOI: / ]. Eur Respir J 2022; 59:
2 TABLE 1 Study outcomes assessed at 6 weeks High-dose prednisolone Low-dose prednisolone Mean difference (95% CI) p-value Patients, n Primary outcome Complete radiological response # 16 (24.6) 12 (18.5) 0.06 ( ) 0.39 Key secondary outcomes Complete/good radiological response # 55 (84.6) 52 (80.0) 0.05 ( ) 0.49 FVC, % predicted 71.1± ± ( ) 0.21 Improvement in resting S po2, + % 2 (0 6) 2 (1 6) 0.91 Improvement in dyspnoea, mmrc score + 1(1 2) 2 (1 2) point improvement + 56 (91.8) 56 (93.3) 0.02 ( ) 1.00 Other secondary outcomes Good composite response # 10 (15.4) 10 (15.4) 0 ( ) 1.00 Oxygen desaturation on exercise + 30 (52.6) 30 (50.8) 0.02 ( ) 0.85 Score on the FACIT-Dyspnea scale ± ± ( ) 0.25 K-BILD total score ± ± ( ) 0.79 Short form-36 component scores + Physical functioning 59.4± ± ( ) 0.49 Role limitation physical 61.5± ± ( ) 0.50 Role limitation emotional 74.9± ± ( ) 0.38 Vitality 59.7± ± ( ) 0.98 Mental health 71.8± ± ( ) 0.35 Social functioning 76.4± ± ( ) 0.15 Bodily pain 75.9± ± ( ) 0.43 General health 63.9± ± ( ) 0.51 Exploratory outcomes 6MWD, m 349±93 318± ( ) 0.15 Improvement in 6MWD, ƒ m 86 (33 128) 70 (43 170) 0.55 Change in chest CT scores +,## Ground-glass opacities 1.01± ± ( ) 0.09 Consolidation 1.16± ± ( ) 0.88 Reticulation 0.08± ± ( ) 0.71 Parenchymal bands 0.14± ± ( ) 0.35 Traction bronchiectasis 0.36± ± ( ) 0.98 Adverse effects # Any 46 (70.8) 50 (76.9) 0.06 ( ) 0.55 Hyperglycaemia 21 (32.3) 19 (29.2) 0.03 ( ) 0.20 Hypertension 15 (23.1) 14 (21.5) 0.02 ( ) 0.83 Cushingoid habitus 13 (20.0) 13 (20.0) 0 ( ) 1.00 Fatigue 9 (13.8) 13 (20.0) 0.06 ( ) 0.48 Weight gain (>10% of baseline) 4 (6.2) 5 (7.7) 0.02 ( ) 1.00 Dyspepsia 3 (4.6) 7 (10.8) 0.06 ( ) 0.19 Others 19 (29.2) 27 (41.5) 0.12 ( ) 0.20 Data are presented as n (%), mean±sd or median (interquartile range), unless otherwise stated. FVC: forced vital capacity; S po2 ; peripheral oxygen saturation; mmrc: modified Medical Research Council; FACIT: Functional Assessment of Chronic Illness Therapy; K-BILD: King s Brief Interstitial Lung Disease; 6MWD: 6-min walk distance; CT: computed tomography. # : outcomes presented for all subjects (n=65 in each group) with the worse outcomes assumed for those who were lost to follow-up; : 59 subjects in the high-dose group and 57 in the low-dose group were able to perform spirometry; + : outcomes reported for patients who completed follow-up (high-dose group n=61, low-dose group n=60); : 57 and 59 subjects could perform the 6-min walk test (6MWT) at 6 weeks in the high-dose and low-dose groups, respectively; ƒ : paired data available for 6MWT for 44 (high-dose group) and 37 (low-dose group) subjects; ## : ground-glass opacities, consolidation, reticulation and parenchymal bands were scored semi-quantitatively in each lobe (right upper lobe, right middle lobe, right lower lobe, left upper lobe/lingula and left lower lobe) on chest CT. A score of 0 indicates no involvement, 1 represents <5% of lobe involved (present but minimal), 2 reflects 5 25%, 3 indicates 25 49%, 4 signifies 50 75% and 5 denotes >75% involvement. For each feature, the lobe scores were summed and divided by five to obtain an average (scale of 0 5), indicating the proportion of the total lung parenchyma showing the feature. Traction bronchiectasis was scored as absent (0) or present (1) for each lobe. The total score for traction bronchiectasis was calculated by summing up the respective scores for the five lobes; : other adverse effects (rarer events with <10 events in the study population) included skin thinning and bruising, insomnia, muscular weakness, mood changes, abdominal pain, infection, headache, visual disturbance, dysgeusia, hypertrichosis and acne. The key secondary outcomes included the proportion of subjects with a complete or good radiological response ( 50% resolution in diffuse lung abnormalities), percentage of predicted forced vital capacity (FVC), improvements in the resting oxygen saturation and dyspnoea severity and adverse effects. 2
3 Between December 2020 and June 2021, we screened 290 subjects and randomised 65 to each group. The major reasons for exclusion were mild lung abnormalities (n=82), contraindications to prednisolone (n=27), consent refusal (n=23) and others (n=28). The study groups had similar baseline characteristics with a mean age of 57 years, 32% women and 73% subjects with at least one comorbidity. All subjects were hospitalised for acute COVID-19 illness. Approximately 98% had either critical or severe disease according to World Health Organization criteria; 43% received either mechanical ventilation or high-flow nasal oxygen. Most (76%) subjects were randomised after hospital discharge (median of 36 days from acute COVID-19 symptom onset and 15 days since hospital discharge). At randomisation, the subjects had a median mmrc dyspnoea score of 3; 88% of subjects had exertional (or resting) hypoxaemia with 27% requiring supplemental oxygen. Approximately 91% had an organising pneumonia pattern on chest CT. The cumulative glucocorticoid dose received during acute COVID-19 management (median dose, 505 mg prednisolone equivalent) was similar between the study groups ( p=0.16). 61 (93.8%) and 60 (92.3%) subjects completed 6 weeks follow-up in the high-dose and low-dose groups, respectively (compliance by cumulative dose, 96.8% and 96.2%, respectively). We found a complete radiological response in 16 (24.6%) and 12 (18.5%) subjects in the high-dose and low-dose groups, respectively ( p=0.39). 55 (84.6%) and 52 (80.0%) subjects had a complete or good radiological response in the respective groups (p=0.49). The mean FVC at 6 weeks was similar (high dose 71.1% pred, low dose 67.4% pred; p=0.21). The median (interquartile range) improvements in resting oxygen saturation (high dose 2 (0 6), low-dose 2 (1 6); p=0.91) and mmrc scale (high dose 1 (1 2), low-dose 2 (1 2); p=0.52) were similar. Only one subject (high-dose group) required supplemental oxygen at 6 weeks. In addition, the other secondary and exploratory outcomes did not differ between the study groups (table 1). The outcomes did not differ by study group allocation in any of the analysed subgroups based on age (<60 years versus 60 years), sex, comorbidity (none versus any), body weight (<80 kg versus 80 kg), duration since COVID-19 onset ( 4 weeks versus >4 weeks), cumulative prednisolone dose before randomisation (<500 mg versus 500 mg), peak oxygen requirement during hospitalisation (fraction of inspired oxygen 0.5 versus >0.5), mechanical ventilation and dyspnoea severity (mmrc grade 2 versus grade 3 or 4). The incidence of treatment-related adverse effects was similar between the study groups (table 1). There were no deaths. Four infections occurred ( pulmonary tuberculosis, tracheostomy site infection, recurrent symptomatic acute COVID-19 in the high-dose group and an uncomplicated urinary tract infection in the low-dose group); all responded to appropriate treatment. To our knowledge, this is the first randomised trial of any therapy for PC-DPLAS. A complete radiological response was achieved in only 21% of subjects; this proportion lies in the higher range of early imaging outcomes previously reported in PC-DPLAS [13 15]. Dyspnoea was reduced by the minimal clinically important difference ( 1 mmrc point) in 92% of subjects, similar between the study groups. We also found significant improvements in oxygen saturation and 6-min walk distance in both groups. However, glucocorticoid therapy was not without harm: 74% of subjects developed at least one adverse effect. Even in the low-dose group, 29% and 22% of patients developed hyperglycaemia and hypertension, respectively. The management of PC-DPLAS remains unclear. Many physicians adopt a wait-and-see approach, administering glucocorticoids, if anything, to patients whose symptoms or hypoxaemia persist beyond several weeks to months [4, 6]. In contrast, several physicians prescribe prolonged high-dose glucocorticoids early in the course of PC-DPLAS [5]. SEGALA et al. [6] treated 10 patients with persistent respiratory failure beyond 3 weeks after acute COVID-19 symptom onset with high-dose intravenous methylprednisolone and observed significant improvements in oxygenation. MYALL et al. [4] treated 30 patients with persistent symptoms and a radiological organising pneumonia pattern with medium-dose prednisolone an average of 11 weeks after symptom onset and reported a significant clinicophysiological response. We administered prednisolone at an average of 5 weeks from acute COVID-19 symptom onset ( 2 weeks from discharge) to patients with PC-DPLAS with considerable ongoing symptoms, oxygenation defects and significant residual radiological abnormalities. We observed similar improvement as previous studies, even with low-dose prednisolone [4, 6]. An important limitation of the study is the lack of a placebo arm. Nevertheless, we did our best to exclude patients with only mild PC-DPLAS. Our inclusion criteria, significant exclusion rate and the baseline radiological and physiological characteristics of our study subjects reflect our attempts to include only patients with persistent and severe PC-DPLAS. Yet, our study cannot answer whether glucocorticoids are required at all for treating PC-DPLAS. It is plausible that our subjects, although significantly symptomatic, 3
4 could have improved spontaneously without any glucocorticoid therapy. However, our study does indicate that a lower glucocorticoid dose may be sufficient once a decision is made to treat persistent PC-DPLAS. Other limitations include the single-study centre, small sample size, short follow-up and unavailability of other pulmonary function tests such as diffusion capacity of the lung. In conclusion, we did not find high-dose prednisolone better than low-dose prednisolone in improving the clinical, radiological, physiological and HRQoL outcomes in PC-DPLAS. A placebo-controlled trial of glucocorticoids is required to better inform clinical practice for treating PC-DPLAS. Sahajal Dhooria 1,5, Shivani Chaudhary 1,5, Inderpaul Singh Sehgal 1, Ritesh Agarwal 1, Siddhant Arora 2, Mandeep Garg 3, Nidhi Prabhakar 3, Goverdhan Dutt Puri 4, Ashish Bhalla 2, Vikas Suri 2, Lakshmi Narayana Yaddanapudi 4, Valliappan Muthu 1, Kuruswamy Thurai Prasad 1 and Ashutosh Nath Aggarwal 1 1 Dept of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India. 2 Dept of Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India. 3 Dept of Radiodiagnosis and Imaging, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India. 4 Dept of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India. 5 These authors contributed equally to the manuscript and may be considered as first authors. Corresponding author: Sahajal Dhooria (sahajal@gmail.com) This trial was prospectively registered at ClinicalTrials.gov with identifier NCT Data collected for the study, including deidentified participant data and related documents, including the protocol, statistical analysis plan and informed consent form, will be made available to qualified researchers after publication of the manuscript upon reasonable request via application to the corresponding author. Conflict of interest: None declared. References 1 Montani D, Savale L, Beurnier A, et al. Multidisciplinary approach for post-acute COVID-19 syndrome: time to break down the walls. Eur Respir J 2021; 58: Garg M, Maralakunte M, Garg S, et al. The conundrum of long-covid-19 : a narrative review. Int J Gen Med 2021; 14: Funke-Chambour M, Bridevaux PO, Clarenbach CF, et al. Swiss recommendations for the follow-up and treatment of pulmonary long COVID. Respiration 2021; 100: Myall KJ, Mukherjee B, Castanheira AM, et al. Persistent post-covid-19 interstitial lung disease. An observational study of corticosteroid treatment. Ann Am Thorac Soc 2021; 18: Kostorz-Nosal S, Jastrzębski D, Chyra M, et al. A prolonged steroid therapy may be beneficial in some patients after the COVID-19 pneumonia. Eur Clin Respir J 2021; 8: Segala FV, Sgalla G, Salvati F, et al. Adjunctive corticosteroid treatment for organizing pneumonia in COVID-19 patients with persistent respiratory failure. Respir Med 2021; 187: Miller MR, Hankinson J, Brusasco V, et al. Standardisation of spirometry. Eur Respir J 2005; 26: Holland AE, Spruit MA, Troosters T, et al. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J 2014; 44: Hinchcliff M, Beaumont JL, Thavarajah K, et al. Validity of two new patient-reported outcome measures in systemic sclerosis: Patient-Reported Outcomes Measurement Information System 29-item Health Profile and Functional Assessment of Chronic Illness Therapy-Dyspnea short form. Arthritis Care Res 2011; 63: Patel AS, Siegert RJ, Brignall K, et al. The development and validation of the King s Brief Interstitial Lung Disease (K-BILD) health status questionnaire. Thorax 2012; 67: Sinha R, van den Heuvel WJ, Arokiasamy P. Validity and reliability of MOS short form health survey (SF-36) for use in India. Indian J Community Med 2013; 38: Petitpierre N, Cottin V, Marchand-Adam S, et al. A 12-week combination of clarithromycin and prednisone compared to a 24-week prednisone alone treatment in cryptogenic and radiation-induced organizing pneumonia. Sarcoidosis Vasc Diffuse Lung Dis 2018; 35: Wu X, Liu X, Zhou Y, et al. 3-month, 6-month, 9-month, and 12-month respiratory outcomes in patients following COVID-19-related hospitalisation: a prospective study. Lancet Respir Med 2021; 9:
5 14 González J, Benítez ID, Carmona P, et al. Pulmonary function and radiologic features in survivors of critical COVID-19: a 3-month prospective cohort. Chest 2021; 160: Shah AS, Wong AW, Hague CJ, et al. A prospective study of 12-week respiratory outcomes in COVID-19-related hospitalisations. Thorax 2021; 76:
This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.
abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical
More informationOxygen - update April 2009 OXG
PRESENTATION Oxygen (O 2 ) is a gas provided in compressed form in a cylinder. It is also available in liquid form, in a system adapted for ambulance use. It is fed via a regulator and flow meter to the
More informationCost-effectiveness of Pirfenidone (Esbriet ) for the treatment of Idiopathic Pulmonary Fibrosis.
Cost-effectiveness of Pirfenidone (Esbriet ) for the treatment of Idiopathic Pulmonary Fibrosis. March 2013 1. Pirfenidone is indicated in adults for the treatment of mild to moderate Idiopathic Pulmonary
More informationRiociguat Clinical Trial Program
Riociguat Clinical Trial Program Riociguat (BAY 63-2521) is an oral agent being investigated as a new approach to treat chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension
More informationJ of Evolution of Med and Dent Sci/ eissn- 2278-4802, pissn- 2278-4748/ Vol. 3/ Issue 65/Nov 27, 2014 Page 13575
EFFECT OF BREATHING EXERCISES ON BIOPHYSIOLOGICAL PARAMETERS AND QUALITY OF LIFE OF PATIENTS WITH COPD AT A TERTIARY CARE CENTRE Sudin Koshy 1, Rugma Pillai S 2 HOW TO CITE THIS ARTICLE: Sudin Koshy, Rugma
More informationSYNOPSIS. Risperidone: Clinical Study Report CR003274
SYNOPSIS Protocol No: CR003274 Title of Study: An Open-Label, Long-Term Trial of Risperidone Long-Acting Microspheres in the Treatment of Subjects Diagnosed with Schizophrenia Coordinating Investigator:
More informationIdiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis What is Idiopathic Pulmonary Fibrosis? Idiopathic pulmonary fibrosis (IPF) is a condition that causes persistent and progressive scarring of the tiny air sacs (alveoli) in
More informationBronchodilators in COPD
TSANZSRS Gold Coast 2015 Can average outcomes in COPD clinical trials guide treatment strategies? Long live the FEV1? Christine McDonald Dept of Respiratory and Sleep Medicine Austin Health Institute for
More informationVITAMIN C AND INFECTIOUS DISEASE: A REVIEW OF THE LITERATURE AND THE RESULTS OF A RANDOMIZED, DOUBLE-BLIND, PROSPECTIVE STUDY OVER 8 YEARS
39 Chapter 3 VITAMIN C AND INFECTIOUS DISEASE: A REVIEW OF THE LITERATURE AND THE RESULTS OF A RANDOMIZED, DOUBLE-BLIND, PROSPECTIVE STUDY OVER 8 YEARS Maxine Briggs TABLE OF CONTENTS I. Review of the
More informationRehabilitation and Lung Cancer Resection. Roberto Benzo MD MS Mindful Breathing Laboratory Division of Pulmonary & CCM Mayo Clinic
Rehabilitation and Lung Cancer Resection Roberto Benzo MD MS Mindful Breathing Laboratory Division of Pulmonary & CCM Mayo Clinic Disclosure Funded by the National Cancer Institute NIH for Preoperative
More informationHistorical Basis for Concern
Androgens After : Are We Ready? Mohit Khera, MD, MBA Assistant Professor of Urology Division of Male Reproductive Medicine and Surgery Scott Department of Urology Baylor College of Medicine Historical
More informationOxygen Therapy. Oxygen therapy quick guide V3 July 2012.
PRESENTATION Oxygen (O 2 ) is a gas provided in a compressed form in a cylinder. It is also available in a liquid form. It is fed via a regulator and flow meter to the patient by means of plastic tubing
More informationPulmonary Diseases. Lung Disease: Pathophysiology, Medical and Exercise Programming. Overview of Pathophysiology
Lung Disease: Pathophysiology, Medical and Exercise Programming Overview of Pathophysiology Ventilatory Impairments Increased airway resistance Reduced compliance Increased work of breathing Ventilatory
More informationDepartment of Surgery
What is emphysema? 2004 Regents of the University of Michigan Emphysema is a chronic disease of the lungs characterized by thinning and overexpansion of the lung-like blisters (bullae) in the lung tissue.
More informationPosition Statement from the Irish Thoracic Society on the treatment of Idiopathic Pulmonary Fibrosis
BACKGROUND Position Statement from the Irish Thoracic Society on the treatment of Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis (IPF) is a rare, chronic and fatal disease characterised by
More informationTests. Pulmonary Functions
Pulmonary Functions Tests Static lung functions volumes Dynamic lung functions volume and velocity Dynamic Tests Velocity dependent on Airway resistance Resistance of lung tissue to change in shape Dynamic
More informationJames F. Kravec, M.D., F.A.C.P
James F. Kravec, M.D., F.A.C.P Chairman, Department of Internal Medicine, St. Elizabeth Health Center Chair, General Internal Medicine, Northeast Ohio Medical University Associate Medical Director, Hospice
More informationDisclosures. Consultant and Speaker for Biogen Idec, TEVA Neuroscience, EMD Serrono, Mallinckrodt, Novartis, Genzyme, Accorda Therapeutics
Mitzi Joi Williams, MD Neurologist MS Center of Atlanta, Atlanta, GA Disclosures Consultant and Speaker for Biogen Idec, TEVA Neuroscience, EMD Serrono, Mallinckrodt, Novartis, Genzyme, Accorda Therapeutics
More informationPsoriasis, Incidence, Quality of Life, Psoriatic Arthritis, Prevalence
1.0 Abstract Title Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients with Psoriasis Severe or Moderate with Adalimumab Treatment (TOGETHER). Keywords Psoriasis,
More informationESCMID Online Lecture Library. by author
Do statins improve outcomes of patients with sepsis and pneumonia? Jordi Carratalà Department of Infectious Diseases Statins for sepsis & community-acquired pneumonia Sepsis and CAP are major healthcare
More informationOutcome of Drug Counseling of Outpatients in Chronic Obstructive Pulmonary Disease Clinic at Thawangpha Hospital
Mahidol University Journal of Pharmaceutical Sciences 008; 35(14): 81. Original Article Outcome of Drug Counseling of Outpatients in Chronic Obstructive Pulmonary Disease Clinic at Thawangpha Hospital
More information2. Background This drug had not previously been considered by the PBAC.
PUBLIC SUMMARY DOCUMENT Product: Ambrisentan, tablets, 5 mg and 10 mg, Volibris Sponsor: GlaxoSmithKline Australia Pty Ltd Date of PBAC Consideration: July 2009 1. Purpose of Application The submission
More informationINITIATING ORAL AUBAGIO (teriflunomide) THERAPY
FOR YOUR PATIENTS WITH RELAPSING FORMS OF MS INITIATING ORAL AUBAGIO (teriflunomide) THERAPY WARNING: HEPATOTOXICITY AND RISK OF TERATOGENICITY Severe liver injury including fatal liver failure has been
More informationDisease/Illness GUIDE TO ASBESTOS LUNG CANCER. What Is Asbestos Lung Cancer? www.simpsonmillar.co.uk Telephone 0844 858 3200
GUIDE TO ASBESTOS LUNG CANCER What Is Asbestos Lung Cancer? Like tobacco smoking, exposure to asbestos can result in the development of lung cancer. Similarly, the risk of developing asbestos induced lung
More informationCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP)
The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use London, 18 December 2002 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON THE
More informationManagement of exacerbations in chronic obstructive pulmonary disease in Primary Care
Management of exacerbations in chronic obstructive pulmonary disease in Primary Care Acute exacerbations of chronic obstructive pulmonary disease (COPD) are associated with significant morbidity and mortality.
More informationScottish Medicines Consortium
Scottish Medicines Consortium pemetrexed 500mg infusion (Alimta ) No. (192/05) Eli Lilly 8 July 2005 The Scottish Medicines Consortium has completed its assessment of the above product and advises NHS
More informationLothian Guideline for Domiciliary Oxygen Therapy Service for COPD
Lothian Guideline for Domiciliary Oxygen Therapy Service for COPD This document describes the standard for clinical assessment, prescription, optimal management and follow-up of patients receiving domiciliary
More informationNATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Health Technology Appraisal. Drugs for the treatment of pulmonary arterial hypertension
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Health Technology Appraisal Drugs for the treatment of Remit / Appraisal objective: Final scope To appraise the clinical and cost effectiveness of
More informationThe patient s response to therapy within the first hour in the Emergency Room is one of the most reliable ways to predict need for hospitalization.
Emergency Room Asthma Management Algorithm The Emergency Room Asthma Management Algorithm is to be used for any patient seen in the Emergency Room with the diagnosis of asthma. (The initial history should
More informationKanıt: Klinik çalışmalarda ZYTIGA
mkdpk de Sonunda Gerçek İlerleme! Kanıt: Klinik çalışmalarda ZYTIGA Dr. Sevil Bavbek 5. Türk Tıbbi Onkoloji Kongresi Mart 214, Antalya Endocrine therapies Adrenals Testis Abiraterone Orteronel Androgen
More informationThis clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.
abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical
More informationSponsor Novartis. Generic Drug Name Secukinumab. Therapeutic Area of Trial Psoriasis. Approved Indication investigational
Clinical Trial Results Database Page 2 Sponsor Novartis Generic Drug Name Secukinumab Therapeutic Area of Trial Psoriasis Approved Indication investigational Clinical Trial Results Database Page 3 Study
More informationSpinal cord stimulation
Spinal cord stimulation This leaflet aims to answer your questions about having spinal cord stimulation. It explains the benefits, risks and alternatives, as well as what you can expect when you come to
More informationAbnormalities Consistent with Asbestos-Related Disease Among Long-Term Demolition Workers
Abnormalities Consistent with Asbestos-Related Disease Among Long-Term Demolition Workers Stephen M. Levin, M.D. Mount Sinai School of Medicine New York, New York November 1994 The Center to Protect Workers
More informationVersion History. Previous Versions. Policy Title. Drugs for MS.Drug facts box Glatiramer Acetate Version 1.0 Author
Version History Policy Title Drugs for MS.Drug facts box Glatiramer Acetate Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review Date Supersedes/New (Further fields
More informationSYNOPSIS. 2-Year (0.5 DB + 1.5 OL) Addendum to Clinical Study Report
Name of Sponsor/Company: Bristol-Myers Squibb Name of Finished Product: Abatacept () Name of Active Ingredient: Abatacept () Individual Study Table Referring to the Dossier (For National Authority Use
More informationPHSW Procedural Sedation Post-Test Answer Key. For the following questions, circle the letter of the correct answer(s) or the word true or false.
PHSW Procedural Sedation Post-Test Answer Key 1 1. Define Procedural (Conscious) Sedation: A medically controlled state of depressed consciousness where the patient retains the ability to continuously
More informationOral Zinc Supplementation as an Adjunct Therapy in the Management of Hepatic Encephalopathy: A Randomized Controlled Trial
Oral Zinc Supplementation as an Adjunct Therapy in the Management of Hepatic Encephalopathy: A Randomized Controlled Trial Marcus R. Pereira A. Study Purpose Hepatic encephalopathy is a common complication
More informationDrugs for MS.Drug fact box cannabis extract (Sativex) Version 1.0 Author
Version History Policy Title Drugs for MS.Drug fact box cannabis extract (Sativex) Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review Date Supersedes/New (Further
More informationSystolic Blood Pressure Intervention Trial (SPRINT) Principal Results
Systolic Blood Pressure Intervention Trial (SPRINT) Principal Results Paul K. Whelton, MB, MD, MSc Chair, SPRINT Steering Committee Tulane University School of Public Health and Tropical Medicine, and
More information2.0 Synopsis. Vicodin CR (ABT-712) M05-765 Clinical Study Report R&D/07/095. (For National Authority Use Only) to Part of Dossier: Volume:
2.0 Synopsis Abbott Laboratories Name of Study Drug: Vicodin CR Name of Active Ingredient: Hydrocodone/Acetaminophen Extended Release (ABT-712) Individual Study Table Referring to Part of Dossier: Volume:
More informationCOPD and Asthma Differential Diagnosis
COPD and Asthma Differential Diagnosis Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of death in America. Learning Objectives Use tools to effectively diagnose chronic obstructive
More informationEfficacy, safety and preference study of a insulin pen PDS290 vs. a Novo Nordisk marketed insulin pen in diabetics
Efficacy, safety and preference study of a insulin pen PDS290 vs. a Novo Nordisk marketed insulin pen in diabetics This trial is conducted in the United States of America (USA). The aim of this clinical
More informationSponsor Novartis Pharmaceuticals
Clinical Trial Results Database Page 1 Sponsor Novartis Pharmaceuticals Generic Drug Name Indacaterol Therapeutic Area of Trial Chronic Obstructive Pulmonary Disease (COPD) Indication studied: COPD Study
More informationNICE Pathways bring together all NICE guidance, quality standards and other NICE information on a specific topic.
bring together all NICE guidance, quality standards and other NICE information on a specific topic. are interactive and designed to be used online. They are updated regularly as new NICE guidance is published.
More informationTest Request Tip Sheet
With/Without Contrast CT, MRI Studies should NOT be ordered simultaneously as dual studies (i.e., with and without contrast). Radiation exposure is doubled and both views are rarely necessary. The study
More informationOnline supplements are not copyedited prior to posting.
Functional Impact of a Spectrum of Interstitial Lung Abnormalities in Rheumatoid Arthritis Tracy J. Doyle, MD, MPH; Paul F. Dellaripa, MD; Kerri Batra, MD; Michelle L. Frits, BA; Christine K. Iannaccone,
More informationThe Global Alliance against Chronic Respiratory Diseases
The Global Alliance against Chronic Respiratory Diseases Pulmonary hypertension Dr Marc Humbert What is the burden of pulmonary hypertension? The true burden of pulmonary hypertension is currently unknown
More informationNHS FORTH VALLEY Multiple Sclerosis Service Management of MS Relapses
NHS FORTH VALLEY Multiple Sclerosis Service Management of MS Relapses Approved 22/06/2010 Version Version 2 Date of First Issue 2002 Review Date 10/05/2016 Date of Issue 01/02/2010 EQIA Yes 22.06.10 Author
More informationIf several different trials are mentioned in one publication, the data of each should be extracted in a separate data extraction form.
General Remarks This template of a data extraction form is intended to help you to start developing your own data extraction form, it certainly has to be adapted to your specific question. Delete unnecessary
More informationEUROPEAN LUNG FOUNDATION
PULMONARY REHABILITATION understanding the professional guidelines This guide includes information on what the European Respiratory Society and the American Thoracic Society have said about pulmonary rehabilitation.
More information6-minute walking distance: covered distance in a quick self-paced walk on a flat, hard surface in a period of 6 minutes
SOP 6-Minute-Walk Test 1. General considerations The self-paced 6-minute walk test (6MWT) is considered as suitable method to objectively assess the submaximal level of functional capacity in children
More informationOmega-3 fatty acids improve the diagnosis-related clinical outcome. Critical Care Medicine April 2006;34(4):972-9
Omega-3 fatty acids improve the diagnosis-related clinical outcome 1 Critical Care Medicine April 2006;34(4):972-9 Volume 34(4), April 2006, pp 972-979 Heller, Axel R. MD, PhD; Rössler, Susann; Litz, Rainer
More informationNatalizumab (Tysabri)
Natalizumab (Tysabri) Spirella Building, Letchworth, SG6 4ET 01462 476700 www.mstrust.org.uk reg charity no. 1088353 Natalizumab (Tysabri) Date of issue: July 2010 Review date: July 2011 Contents Section
More informationClinical bottom line. For more detailed evidence on the effectiveness of injections for tennis elbow, please see the CAT on:
Short Question: Specific Question: In patients presenting with acute or chronic tendinopathies, what is the incidence of harm for those receiving steroid injections compared to those receiving usual care?
More informationFREEDOM C: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C
FREEDOM C: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C SR in Combination with an ERA and/or a PDE-5 Inhibitor
More informationMANCHESTER Lung Cancer Screening Program Dartmouth-Hitchcock Manchester 100 Hitchcock Way Manchester, NH 03104 (603) 695-2850
LEBANON Lung Cancer Screening Program One Medical Center Drive Lebanon, NH 03756 (603) 650-4400 (866) 966-1601 Toll-free cancer.dartmouth.edu/lungscreening MANCHESTER Lung Cancer Screening Program Dartmouth-Hitchcock
More informationCoding Guidelines for Certain Respiratory Care Services July 2014
Coding Guidelines for Certain Respiratory Care Services Overview From time to time the AARC receives inquiries about respiratory-related coding and coverage issues through its Help Line or Coding Listserv.
More informationIntravenous Methyl Prednisolone in Multiple Sclerosis
Intravenous Methyl Prednisolone in Multiple Sclerosis Exceptional healthcare, personally delivered Relapse management in multiple sclerosis Relapses in multiple sclerosis (MS) are common and caused by
More informationUse of Azithromycin in Children with Non-Cystic Fibrosis Bronchiectasis or Chronic Suppurative Lung Disease
Use of Azithromycin in Children with Non-Cystic Fibrosis Bronchiectasis or Chronic Suppurative Lung Document ID CHQ-GDL-01061 Version no. 2.0 Approval date 28/08/2015 Executive sponsor Executive Director
More informationRELAPSE MANAGEMENT. Pauline Shaw MS Nurse Specialist 25 th June 2010
RELAPSE MANAGEMENT Pauline Shaw MS Nurse Specialist 25 th June 2010 AIMS OF SESSION Relapsing/Remitting MS Definition of relapse/relapse rate Relapse Management NICE Guidelines Regional Clinical Guidelines
More informationPhase: IV. Study Period: 20 Jan. 2006-17 Sep. 2008
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationLife Insurance Application Form
Life Insurance Application Form INSTRUCTION To be completed by all applicants PERSONAL DETAILS Surname First name Middle name Sex Female Male Marital status (please tick) Single Married Other Current residential
More informationAssessment of pulmonary function in rheumatoid arthritis patients attending Rheumatology Clinics in Nairobi
1 College of Health Sciences, University of Nairobi, Nairobi, Kenya 2 Kenyatta National Hospital, Nairobi, Kenya 3 KAPTLD, Nairobi, Kenya Corresponding author: Dr. I. Biomdo, Department of Internal Medicine,
More informationMore detailed background information and references can be found at the end of this guideline
Neonatal Intensive Care Unit Clinical Guideline Oxygen Over the past few years there have been significant changes, based on high quality research, in our understanding of how to give the right amount
More informationSteroids. What are steroids?
Steroids What are steroids? Also known as corticosteroids and glucocorticoids, steroids are hormones that are normally produced by the adrenal glands. They are mainly used in multiple sclerosis (MS) because
More informationPLAN OF ACTION FOR. Physician Name Signature License Date
PLAN OF ACTION FOR Patient s copy (patient s name) I Feel Well Lignes I feel short directrices of breath: I cough up sputum daily. No Yes, colour: I cough regularly. No Yes I Feel Worse I have changes
More informationMedicare C/D Medical Coverage Policy
Medicare C/D Medical Coverage Policy Oxygen and Oxygen Supplements Origination: April 10, 1992 Review Date: July 15, 2015 Next Review: July, 2017 DESCRIPTION OF PROCEDURE OR SERVICE USP Oxygen is a gaseous
More informationPG Certificate / PG Diploma / MSc in Clinical Pharmacy
PG Certificate / PG Diploma / MSc in Clinical Pharmacy Programme Information September 2014 Entry School of Pharmacy Queen s University Belfast Queen s University Belfast - Clinical Pharmacy programme
More informationEVIDENCE BASED TREATMENT OF CROHN S DISEASE. Dr E Ndabaneze
EVIDENCE BASED TREATMENT OF CROHN S DISEASE Dr E Ndabaneze PLAN 1. Case presentation 2. Topic on Evidence based Treatment of Crohn s disease - Introduction pathology aetiology - Treatment - concept of
More informationCT scans and IV contrast (radiographic iodinated contrast) utilization in adults
CT scans and IV contrast (radiographic iodinated contrast) utilization in adults At United Radiology Group, a majority of CT exams are performed either with IV contrast or without while just a few exams
More informationMarilyn Borkgren-Okonek, APN, CCNS, RN, MS Suburban Lung Associates, S.C. Elk Grove Village, IL
Marilyn Borkgren-Okonek, APN, CCNS, RN, MS Suburban Lung Associates, S.C. Elk Grove Village, IL www.goldcopd.com GLOBAL INITIATIVE FOR CHRONIC OBSTRUCTIVE LUNG DISEASE GLOBAL STRATEGY FOR DIAGNOSIS, MANAGEMENT
More informationPATIENT INFORMATION SHEET
PATIENT INFORMATION SHEET Surgical and large bore pleural procedures in Malignant pleural Mesothelioma And Radiotherapy Trial (SMART trial) Stoke Mandeville Hospital Mandeville Road Aylesbury Buckinghamshire
More informationExploratory data: COPD and blood eosinophils. David Price: 9.23-9.35am
Exploratory data: COPD and blood eosinophils David Price: 9.23-9.35am Blood Eosinophilia in COPD The reliability and utility of blood eosinophils as a marker of disease burden, healthcare resource utilisation
More informationPULMONARY FUNCTION TESTS A Workshop on Simple Spirometry & Flow Volume Loops
PULMONARY FUNCTION TESTS A Workshop on Simple Spirometry & Flow Volume Loops YOU SHOULD READ THE FOLLOWING MATERIAL BEFORE Tuesday March 30 Interpretation of PFTs Learning Objectives 1. Specify the indications
More informationThe influence of exercise modality on dyspnoea perception during cardiopulmonary exercise testing in obese patients with COPD
ONLINE SUPPLEMENT The influence of exercise modality on dyspnoea perception during cardiopulmonary exercise testing in obese patients with COPD Casey E. Ciavaglia, Jordan A. Guenette, Josuel Ora, Katherine
More informationMILITARY (ACTIVE DUTY)-SPECIFIC ISSUES
RECOMMENDATIONS MILITARY (ACTIVE DUTY)-SPECIFIC ISSUES Evaluation for possible asthma 1. Active duty service members should be diagnosed with asthma or exerciseinduced bronchospasm on the basis of the
More informationVersion History. Previous Versions. Drugs for MS.Drug facts box fingolimod Version 1.0 Author
Version History Policy Title Drugs for MS.Drug facts box fingolimod Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review Date Supersedes/New (Further fields as required
More informationASK A DOC. Clinical Trial Update May 28, 2014. Welcome!
ASK A DOC Clinical Trial Update May 28, 2014 Welcome! ASK A DOC CLINICAL TRIAL UPDATE Dr. Gregory Cosgrove PFF Chief Medical Officer Dr. Kevin Flaherty Chairman Steering Committee PFF CCN and PFF Registry
More informationPulmonary rehabilitation
29 Pulmonary rehabilitation Background i Key points There is a sound evidence base showing the effects of pulmonary rehabilitation on chronic obstructive pulmonary disease symptoms and health-related quality
More informationCo-morbiditeit associeert met respiratoire aandoeningen louter omwille van de leeftijd. COPD patiënten hebben veel meer kans op longkanker dan rokers
Academisch centrum huisartsgeneeskunde Pneumologie Juni 2012 Prof W Janssens Co-morbiditeit associeert met respiratoire aandoeningen louter omwille van de leeftijd. COPD patiënten hebben veel meer kans
More informationNalmefene for reducing alcohol consumption in people with alcohol dependence
Nalmefene for reducing alcohol consumption in people with alcohol dependence Issued: November 2014 guidance.nice.org.uk/ta325 NICE has accredited the process used by the Centre for Health Technology Evaluation
More informationA Telehomecare monitoring project in Cystic Fibrosis
ICEHTM 2011 1st International Conference on E-HEALTH and TELEMEDICINE 10-12 October 2011 Nicosia - North Cyprus A Telehomecare monitoring project in Cystic Fibrosis Murgia F, Alghisi F, Majo F, Montemitro
More informationPulmonary Rehabilitation: more than just an exercise prescription
Pulmonary Rehabilitation: more than just an exercise prescription Robert Stalbow, RRT, RCP Pulmonary Rehabilitation Therapist Oregon Heart & Vascular Institute Objectives To describe the role of pulmonary
More informationManaging depression after stroke. Presented by Maree Hackett
Managing depression after stroke Presented by Maree Hackett After stroke Physical changes We can see these Depression Emotionalism Anxiety Confusion Communication problems What is depression? Category
More informationAdjunctive psychosocial intervention. Conditions requiring dose reduction. Immediate, peak plasma concentration is reached within 1 hour.
Shared Care Guideline for Prescription and monitoring of Naltrexone Hydrochloride in alcohol dependence Author(s)/Originator(s): (please state author name and department) Dr Daly - Consultant Psychiatrist,
More informationGUIDELINE Sinusitis. David M. Poetker MD, MA Associate Professor. Division of Rhinology and Sinus Surgery
GUIDELINE Sinusitis David M. Poetker MD, MA Associate Professor Division of Rhinology and Sinus Surgery Guideline Fokkens et al. The European Position Paper on Rhinosinusitis and Nasal Polyps 2012. Rhinology.
More informationNovartis Gilenya FDO Program Clinical Protocol and Highlights from Prescribing Information (PI)
Novartis Gilenya FDO Program Clinical Protocol and Highlights from Prescribing Information (PI) Highlights from Prescribing Information - the link to the full text PI is as follows: http://www.pharma.us.novartis.com/product/pi/pdf/gilenya.pdf
More informationLung Cancer Multidisciplinary Meeting Toolkit. National Lung Cancer Working Group
Lung Cancer Multidisciplinary Meeting Toolkit National Lung Cancer Working Group September 2014 Contents Introduction 1 Multidisciplinary meetings 1 Toolkit for implementing high-quality lung cancer MDMs
More informationSARCOIDOSIS. Signs and symptoms associated with specific organ involvement can include the following:
SARCOIDOSIS Sarcoidosis is a disease that occurs when areas of inflammation develop in different organs of the body. Very small clusters of inflammation, called granulomas, are seen with sarcoidosis. They
More informationIdiopathic Pulmonary Fibrosis (IPF) Research
Idiopathic Pulmonary Fibrosis (IPF): Why Early Referral is Critical Even if Your Patient is Not Eligible for a Clinical Trial Idiopathic Pulmonary Fibrosis (IPF) Research Management of IPF requires a confident
More informationMedication Policy Manual. Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012
Medication Policy Manual Policy No: dru283 Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012 Committee Approval Date: December 12, 2014 Next Review Date: December 2015 Effective Date: January
More informationLow-dose CT Imaging. Edgar Fearnow, M.D. Section Chief, Computed Tomography, Lancaster General Hospital
Lung Cancer Screening with Low-dose CT Imaging Edgar Fearnow, M.D. Section Chief, Computed Tomography, Lancaster General Hospital Despite recent declines in the incidence of lung cancer related to the
More informationGENERAL INFORMATION. Adverse Event (AE) Definition (ICH GUIDELINES E6 FOR GCP 1.2):
Make copies of the blank SAE report form as needed. Retain originals with confirmation of all information faxed to DMID Pharmacovigilance Group Clinical Research Operations and Management Support (CROMS
More informationto Part of Dossier: Name of Active Ingredient: Title of Study: Quality of life study with adalimumab in rheumatoid arthritis. ESCALAR.
2.0 Synopsis Abbott Laboratories Name of Study Drug: Individual Study Table Referring to Part of Dossier: Adalimumab (HUMIRA) (For National Authority Use Only) Name of Active Ingredient: Adalimumab Title
More informationOxygenation. Chapter 21. Anatomy and Physiology of Breathing. Anatomy and Physiology of Breathing*
Oxygenation Chapter 21 Anatomy and Physiology of Breathing Inspiration ~ breathing in Expiration ~ breathing out Ventilation ~ Movement of air in & out of the lungs Respiration ~ exchange of O2 & carbon
More informationNHS FORTH VALLEY Neonatal Oxygen Saturation Guideline
NHS FORTH VALLEY Neonatal Oxygen Saturation Guideline Date of First Issue 11/07/2011 Approved 30/09/2011 Current Issue Date 07/09/2011 Review Date July 2013 Version 1 EQIA Yes 22/10/2011 Author / Contact
More informationShort-term improvement in exercise capacity and symptoms following exercise training in interstitial lung disease
Thorax Online First, published on February 1, 2008 as 10.1136/thx.2007.088070 Short-term improvement in exercise capacity and symptoms following exercise training in interstitial lung disease AE Holland
More informationA Phase 2 Study of Interferon Beta-1a (Avonex ) in Ulcerative Colitis
A Phase 2 Study of (Avonex ) in Ulcerative Colitis - Study Results - ClinicalTrials.gov A Phase 2 Study of (Avonex ) in Ulcerative Colitis This study has been completed. Sponsor: Biogen Idec Information
More information